Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

November 5, 2007 updated by: Azad University of Medical Sciences

Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial

To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.

Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).

Study Type

Interventional

Enrollment

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 13456/7889
        • Azad University of Medical Sciences, Boo-Ali Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pain at the lateral side of the elbow
  • pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
  • pain to be continued for longer than 6 weeks or even with recurrent pain during similar period

Exclusion Criteria:

  • previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
  • patients who were unable to return for follow up
  • patients with nerve entrapment
  • pregnancy
  • breast-feeding
  • presence of systemic neuromuscular disorders such as myasthenia gravis
  • upper limb fractures
  • other arm/forearm pathology such as radial nerve compression
  • known thrombocytopenia
  • coagulopathy or bleeding diathesis
  • history of diffuse pain syndrome
  • history of inflammatory arthropathy
  • intolerance/allergy to corticosteroids or NSAIDs or any contraindication for these
  • untreated depression
  • history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
visual analogue scale (VAS)

Secondary Outcome Measures

Outcome Measure
Patient's satisfaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azad University of Medical Sciences

Investigators

  • Principal Investigator: Jaleh Hassanloo, MD, Department of Orthopedics, Boo-Ali Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 7, 2007

Study Record Updates

Last Update Posted (Estimate)

November 7, 2007

Last Update Submitted That Met QC Criteria

November 5, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-246910-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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